Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080426
Company: BAUSCH
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CETACORT | HYDROCORTISONE | 1% | LOTION;TOPICAL | Discontinued | None | No | No |
CETACORT | HYDROCORTISONE | 0.5% | LOTION;TOPICAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/22/1971 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/20/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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07/19/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
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03/18/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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04/23/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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04/23/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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10/29/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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11/04/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |